Supply Chain Quality Officer (Egypt-Sudan) - Pfizer

• Position: Supply Chain Quality Officer ( Egypt-Sudan)

  Reports to: Supply Chain Quality Egypt-Sudan Market Lead

  Organization overview

  The key role of Pfizer SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pizer and any contractor related to GMP/GDP activities, so that compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk are ensured. SCQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant stakeholders and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the PCO to ensure that current regulatory expectations are met and facilitates internal and regulatory GDP inspections.

  Role description and Main responsibilities

  Maintenance of the compliance to the local BOH regulations

  • Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.
  • Act as the Qualified / Responsible Person to local authorities or support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market. 

  2. Governance & internal organization

  • Supports timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO.
  • Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs. 
  • Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required.
  • Conducts and documents periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCQ) within the PCO.
    Quality Metrics

  • Collects data and reports quality metrics of PCO and contractors to allow quality performance assessment.
  • Together with the SCQ Manager/ Sr Manager, assess quality performance to identify trends and improvement opportunities.
  • Participates in the PCO/Contractors quality management reviews and follows-up for the recommended actions, when required.
    Training

  • Support the implementation of all elements of SCQ Training systems in PCO, including implementation and annual training on GDP/GMP to applicable PCO colleagues.
  • Ensure that all assigned Pfizer trainings (P2L for example) are completed in timely manner                                                                                          
    Commitment Tracking

  • Uses and maintains tracking tools to track any GxP commitments raised by SCQ or under SCQ oversight.
  • For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that the timeframes given are realistic, to meet the stated requirements.

  Change Controls

  • Handles any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.
  • Participates in the changes committee as appropriate and ensures the required approvals.
  • Ensures change actions completion as per the agreed timelines.
    Inspection and Internal Audit

  • Participate in preparation and coordination of external and Pfizer internal inspections and audits.                                                            

  • supports the development of CAPA plans and follow-up to the timely closure in coordination with other relevant functions.
  • Internal self-inspection process management :
    Support / Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.

                                                                                                                                                 

  3 Product quality assurance & operations

  Notification to Management

  • Informs SCQ manager of any significant deviations and complaints, that could lead into a NTM.                                                                                   
  • Ensure notification is done within the appropriate timeline and process.   
    Deviation Management

  • Perform, if needed, investigation of product quality incidents that occur within the responsibility of Pfizer country office in cooperation with the relevant internal/external functions.       
  • Track the preventive and corrective actions until completion within the set due dates.    
                                                                                                                                       
    Product Complaint   Handling                                                                                                                                 
  • Manage the intake and triage of complaints from the markets under PCO responsibility, classify  the product complaint, and forwards them to the appropriate investigating PGS/Contractor manufacturing site via the global complaints management system (QTS-CITI).      
  • Develops and issues responses to complainants in a timely manner           
  • Tracks complaint responses.                                                                          
  • Notifies the Management when needed.

                                                                                                       

                                                                                     

  Local Product Disposition & Temperature excursion

  • Review all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Pfizer procedures.                                                                  
  • Communicate the disposition decision with internal and external stakeholders.                                                                                                    
  • Document any temperature excursion and coordinate with manufacturing site for assessment and via the global Quality Tracking System  (QTS).   

  Local Repackaging/Relabeling operations

  • Ensures that contractors have been assessed and approved before performing any relabeling/repackaging activity.                                            
  • Depending on the local model/ structure, if needed, obtains Regulatory approval of the repackaging/relabeling activity.
  • Completes the required documentation and obtains the necessary approvals from Pfizer Regulatory functions and manufacturing sites.        
  • Oversees the process of repackaging/relabeling and reviews operation related documents.           
  • Releases the repackaged/relabeled products according to the local decision matrix or according to the Manager/ Sr Manager instructions.                                                                                                    

  Returns

  • Assess the returned goods and provide a disposition decision
    Quarantine Alert Notices (special situation)

  • Receives and manages Quarantine Alert Notices (QAN) issued by Pfizer manufacturing site, Contractor manufacturing site or distribution center.         
  • Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold                                                                         
  • Provide the required responses to QAN issuing site on timely manner.      
  • Ensure status of impacted batches is aligned with the final disposition decided by QAN issuing site.                                                                
                                                                                                                                       
    Market Action (special situation)

  • Attend, as needed, Area Quality Review Teams (AQRT) meetings, as PCO representative, to provide the local perspective on the issue at hand.                                                                                                  
  • Support SCQ manager to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the PCO.                                                                      
  • Support  the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions                                                                                                                       

  4. LSP / contractor management & oversight

  • Participates as needed in contactors visits/ audits.  
  • Reviews, negotiates and tracks, according to the Manager/ Sr Manager instructions and maintain up to date Quality Agreements of GMP/GDP contractors.
    Quality agreements

  • Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions.           

   Qualifications/ Skills

                                                                                                                       

  Years of experience: 3-7 years in the Pharmaceutical or related regulated industry   

  Technical skills

  • Has an appropriate education in science or quality topics; Bachelor's degree, pharmacist, Engineer.
  • Has basic knowledge of the Quality principles, concepts of Quality and basic technical skills
  • Has basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)
  • Able to Participate effectively in cross-functional team
  • Analytical skills
  •  Basic level in English 

  Soft skills/ Management & Leadership Skills

  • Self-motivated, Business acumen
  • Act Assertively
  • Grows Self
  • Accountable
  • Change Agile
  • Self-Awareness
  • Planning & Organizing skills
  • Able to Make decisions within guidelines and policies

  Success criteria

  • To use new ideas and knowledge with increasing frequency, Begins to explore and apply ingenuity to experimentation   .
  • Able to work in ambiguous situations as part of a Work Team
  • Applies technical skills to achieve assigned tasks
  • Has effective communication, writing   and negotiation skills
  • Able to align with global strategies
  • Efficiently represents Quality Compliance positions

  Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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